Collaborative Institutional Training Initiative (CITI)
Investigators wishing to conduct research with human subjects through Chapman University MUST complete the appropriate Collaborative Institutional Training Initiative (CITI) course modules, prior to submitting to the IRB. The CITI modules provide research ethics education to the Chapman research community.
Investigators must affiliate with Chapman University when they register with CITI. Under such affiliation, the appropriate CITI course(s), as listed below, must be completed by each investigator on each research team, prior to IRB review. Investigators who are currently registered through other institutions must add Chapman University as an additional affiliation so that CITI course credits earned at other institutions can carry over to the investigator’s CITI profile under Chapman and only course content specific to Chapman would need completion.
- Social and behavioral researchers: complete the course “Social & Behavioral Research Investigators” (the course “Social and Behavioral Responsible Conduct of Research Course” is only a supplement/is optional, and does not replace the “Social & Behavioral Research Investigators” course)
- Biomedical or clinical researchers: complete the course “Biomedical Research Investigators” (the course “Biomedical Responsible Conduct of Research Course” is only a supplement/is optional, and does not replace the “Biomedical Research Investigators” course)
Training in Good Clinical Practices (GCP): Researchers involved in the design, conduct, oversight, or management of a clinical trial as defined by NIH should be trained in GCP. As a condition of protocol approval, the Chapman IRB will require evidence that the Principal Investigator (PI), Co-PI’s, Primary Contact, and any research study team members deemed by the PI, have completed GCP training within the last 3 years. Researchers should complete the applicable CITI GCP course depending on the classification of the research:
- GCP for Clinical Investigations of Devices
- GCP - Social and Behavioral Research Best Practices for Clinical Research
Note that this GCP training is in addition to basic IRB human subjects training required for researchers on expedited and full board review studies.
After the required CITI modules are completed, investigators must complete the modules once every three years. Completion time of the required module(s) can range between 30 minutes to a few hours, as modules can be completed at each investigator's own pace and leisure.
NOTE: An IRB application cannot be processed until all personnel have completed the required CITI Training.